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The Neuroimage Study of the Neuromuscular Disorders.

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National Taiwan University

Status

Enrolling

Conditions

Neuromuscular Diseases

Treatments

Diagnostic Test: Quantitative sensory test
Diagnostic Test: Neuromuscular ultrasound
Diagnostic Test: Muscle and nerve biopsy
Diagnostic Test: Laboratory of blood chemical substances, metals and endocrine profiles
Diagnostic Test: Nerve excitability study
Diagnostic Test: fMRI acquisition and image analysis
Diagnostic Test: Muscle MRI
Diagnostic Test: Genomics, transcriptome, and proteomics
Diagnostic Test: Contact heat evoked potentials
Diagnostic Test: Transcranial magnetic stimulation (TMS)
Diagnostic Test: Skin biopsy
Diagnostic Test: Nerve conduction studies and autonomic function tests

Study type

Observational

Funder types

Other

Identifiers

NCT05048862
201705058RIND

Details and patient eligibility

About

The neuromuscular disorders could be briefly divided to neuropathy, myopathy, motor neuron disease, and neuromuscular junction disorder. In the past, the evaluation of the neuromuscular disorders depended on several ways (ex. electrodiagnostic studies and biopsy) to evaluate the pathophysiology and the pathological change. However, due to the issue of resolution, few image studies were available to evaluate the structure for clinical practice. With the growing techniques, there are two ways to see the nerve and muscle in vivo, the magnetic resonance imaging (MRI) and the ultrasonography. The availability of the machine, the high cost, inability to change the position for dynamic views of the nerves, and the relative invasion considering the large energy penetrating the patient might limit the clinical use of MRI. The nerve ultrasonography is a safe and easily available technique. The development of high-frequency transducers has led to an improvement in the resolution of ultrasonography and enables the exploration of peripheral nerve and muscle structural changes. In additional to evaluate the morphological changes, ultrasonography has been used extensively for the vessel status assessment through duplex ultrasound. In present study, we will apply variable approaches, including to muscle, nerve, and skin biopsy, electrophysiological study, quantitative sensory testing, autonomic functional tests, pain evoked potentials, MRI, and ultrasonography to integrally investigate the different aspects of neuromuscular disorders. The results of the study will provide integrated insights of (1) the neurophysiology of nerve and vessels and (2) pathogenesis of different neuromuscular disorders.

Full description

This is a prospective observational study which will be performed in both the inpatient and outpatient setting of National Taiwan University Hospital. Patients age at least 20 years, and have been diagnosed as neuromuscular disorders by the neurologist. Patients who are unable to read the questionnaire, fail to accept all the examinations, and refuse to provide inform consent are excluded from this study. The normal group (age at least 20 years) who had no neurological symptoms or signs were also recruited. The neurological examination performed by the board neurologist must be normal in the normal group.

Different interventions were performed periodically to see the serial change. The interval between the interventions is within 1 month and there is no new symptoms or any events.

Enrollment

500 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Neuromuscular group):

  • been diagnosed as neuromuscular disorders by the neurologist
  • at least 20-year-old

Inclusion Criteria (Normal group):

  • no past history of neurological disorders.
  • The neurological examination performed by the board neurologist must be normal
  • at least 20-year-old

Exclusion Criteria (Neuromuscular and normal group):

  • Patients who are unable to read the questionnaire, fail to accept all the examinations, and refuse to provide inform consent

Trial design

500 participants in 2 patient groups

Neuromuscular disorder
Description:
Patients age at least 20 years, and have been diagnosed as neuromuscular disorders by the neurologist. Patients who are unable to read the questionnaire, fail to accept all the examinations, and refuse to provide inform consent are excluded from this study.
Treatment:
Diagnostic Test: Nerve conduction studies and autonomic function tests
Diagnostic Test: Laboratory of blood chemical substances, metals and endocrine profiles
Diagnostic Test: Skin biopsy
Diagnostic Test: Transcranial magnetic stimulation (TMS)
Diagnostic Test: Contact heat evoked potentials
Diagnostic Test: Muscle and nerve biopsy
Diagnostic Test: Genomics, transcriptome, and proteomics
Diagnostic Test: Muscle MRI
Diagnostic Test: Neuromuscular ultrasound
Diagnostic Test: fMRI acquisition and image analysis
Diagnostic Test: Quantitative sensory test
Diagnostic Test: Nerve excitability study
Normal group
Description:
The normal group (age at least 20 years) who had no neurological symptoms or signs were also recruited. The neurological examination performed by the board neurologist must be normal in the normal group.
Treatment:
Diagnostic Test: Nerve conduction studies and autonomic function tests
Diagnostic Test: Laboratory of blood chemical substances, metals and endocrine profiles
Diagnostic Test: Transcranial magnetic stimulation (TMS)
Diagnostic Test: Contact heat evoked potentials
Diagnostic Test: Genomics, transcriptome, and proteomics
Diagnostic Test: Muscle MRI
Diagnostic Test: Neuromuscular ultrasound
Diagnostic Test: fMRI acquisition and image analysis
Diagnostic Test: Quantitative sensory test
Diagnostic Test: Nerve excitability study

Trial contacts and locations

1

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Central trial contact

Hsueh-Wen Hsueh, MD, MMS

Data sourced from clinicaltrials.gov

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